Preliminary Study on the Diagnostic Value of 18F-FAPI-04 PET/CT and PET/MR in Patients With Various Types of Malignant Tumors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 1
- 主要终点
- Diagnostic Performance
研究概览
简要总结
To evaluate the potential usefulness of 18F-FAPI-04 positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging （PET/MR）for the diagnosis of primary and metastatic lesions, detection of recurrence or assessment of pathologic response in various types of cancer.
详细描述
Subjects with various types of cancer underwent 18F-FAPI-04 PET/CT and PET/MR imaging either for an initial assessment, recurrence detection or assessment of pathologic response. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and tumor to background (TBR). Using histopathology and follow-up as gold standard, the sensitivity, specificity, positive predictive value (PPV), negative predictive value (NPV) and accuracy of 18F-FAPI-04 PET/CT and PET/MR were calculated.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with suspected or new diagnosed or previously treated malignant tumors (supporting evidence may include MRI, CT, tumor markers and pathology report); patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee.
排除标准
- •patients with non-malignant lesions; patients with pregnancy; the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.
结局指标
主要结局
Diagnostic Performance
时间窗: 1 year
Diagnostic accuracy, The sensitivity, specificity and accuracy of 18F-FAPI-04 PET/CT and PET/MR were calculated.
次要结局
未报告次要终点
研究者
Hui Ye
Professor
Hunan Cancer Hospital